RECRUITING

Defibrotide for the Treatment of Severe COVID-19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.

Official Title

A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19

Quick Facts

Study Start:2021-01-01

Study Completion:2025-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04652115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18 years. 2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR. 3. Radiographic evidence of bilateral pulmonary infiltrates. 4. A life expectancy of at least 24 hours. 5. Score of 4-7 on the WHO ordinal scale. 6. Prophylactic dose anticoagulation is allowed for enrollment into cohort 1. Therapeutic dose anticoagulation for active thrombosis, ECMO, and/or continuous renal replacement therapy (CRRT) is allowed for enrollment into cohort 2 if there is no evidence of bleeding after at least 24 hours of anticoagulation. 7. Patient or surrogate able to provide informed consent	1. Clinically significant acute bleeding. 2. Concomitant use of thrombolytic therapy (e.g. t-PA). 3. Hemodynamic instability, defined as a requirement for \>1 vasopressor agent for enrollment into cohort 1, and a requirement for \>2 vasopressor agents for enrollment into cohort 2 4. Known allergy or hypersensitivity to DF. 5. Pregnant or lactating.

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years.
2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
3. Radiographic evidence of bilateral pulmonary infiltrates.
4. A life expectancy of at least 24 hours.
5. Score of 4-7 on the WHO ordinal scale.
6. Prophylactic dose anticoagulation is allowed for enrollment into cohort 1. Therapeutic dose anticoagulation for active thrombosis, ECMO, and/or continuous renal replacement therapy (CRRT) is allowed for enrollment into cohort 2 if there is no evidence of bleeding after at least 24 hours of anticoagulation.
7. Patient or surrogate able to provide informed consent

1. Clinically significant acute bleeding.
2. Concomitant use of thrombolytic therapy (e.g. t-PA).
3. Hemodynamic instability, defined as a requirement for \>1 vasopressor agent for enrollment into cohort 1, and a requirement for \>2 vasopressor agents for enrollment into cohort 2
4. Known allergy or hypersensitivity to DF.
5. Pregnant or lactating.

Contacts and Locations

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02214

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-01

Study Completion Date2025-03-01

Study Record Updates

Study Start Date2021-01-01

Study Completion Date2025-03-01

Terms related to this study

Additional Relevant MeSH Terms

Covid19